Frequently Asked Questions

Q: What is SureSource?

Our SureSource® Platform is a study driven eSource solution that captures clinical source data and documents the moment information is collected or recorded. This provides trial sponsors, investigators, and patients the real-time visibility they need to help improve adherence to protocol execution, reduce trial risk, and improve patient safety and engagement. By capturing clinical data at the moment it happens, SureSource can help reduce investigator errors, allows sponsors to optimize monitoring activities, and reduce times to data lock.

Q: How does SureSource differ from Electronic Data Capture (EDC)?

Unlike EDC, SureSource eliminates costly, error-prone and time consuming paper source data capture and data transcription. SureSource captures data electronically at the point of care — eliminating the time, costs and burden associated with paper-based EDC systems. Data captured at the site using the SureSource platform is then instantly available for review within our web based portal. Study team members have access to not only the data, but the actual source documents from which the data originated, making SureSource the only solution to truly facilitate centralized (remote) monitoring.

EDC

Q: How is SureSource used in a study?

Studies using SureSource typically follow a multi-step process designed to streamline clinical research, from Start to Submit. During the first step, (study build), sponsors work with Clinical Ink to develop electronic forms (eSource) in the SureSource Launch design tool that sites use to capture study data. From there, site interact with the SureSource Capture module to collect data electronically during the subject visit using a tablet-based application. Intuitively-designed eSource forms reflect the clinical workflow and look just like traditional paper source, but incorporate all CRF data fields and edit checks. To further streamline workflow, some studies will connect with many common supporting technologies (i.e. IVRS, CTMS, device integrations), using our SureSource Connect capabilities, for advanced features including audio file uploads, push-button randomization and automated SAE notifications. To manage studies, sponsors/CROs/sites use the SureSource Insight module which is an interactive web-based portal that enables remote review of source documents and CRF data to issue queries and track metrics. During the final submit step, sponsors can leverage our SureSource Submit capabilities to distribute real-time clinical data formatted according to their existing specifications, including SDTM data formats.

Q: Is SureSource accepted by regulators?

SureSource is one of the only platform that meets all FDA guidelines for eSource, as outlined in Agency’s September 2013 final guidance on electronic source (eSource). In this guidance, FDA clearly states, “this guidance promotes capturing source data in electronic form” and “encourages entering source data during a subject visit” for “real-time access for data review.” Similarly, the EMA has also issued an eSource guidance document consistent with the FDA. SureSource has successfully completed a site audit by MHRA and supports the principles outlined in the FDA’s August 2013 final risk-based monitoring guidance by providing access to source documents for remote review and monitoring.

Q: How does SureSource meet privacy standards?

SureSource has administrative functions that limit access to patient data by geographic location, user role, and form permissions. These same restrictions can be applied to enforce study blinding rules.

Q: How does SureSource help sites become more efficient?

According to a 2015 survey of SureSource site users, more than half of all users reported a significant reduction in data queries and overall workload, including:

70% of all users who reported a drop in queries claim a reduction of > 40%.

82% of users who reported a drop in their overall workload said it dropped by > 20%

28% of users who reported a drop in their overall workload said it dropped by > 50%

Q: Where is the Case Report Form?

The purpose of a CRF is to populate the clinical database, however 2013 FDA eSource guidance encourages entering clinical data directly into the eCRF with no paper transcription step necessary. In these cases, the SureSource form (eSource) is also the CRF — there is no separate CRF. The difference is that SureSource forms have additional source fields as compared to traditional CRFs. When viewing a source form on our Insight portal, highlighted fields denote to a study team member which fields are the exported or CRF fields within a form.

Q: What is the typical study build timeline?

The SureSource study build is comparable to existing EDC study builds and normally requires 8-10 weeks from final protocol and CRF data specifications. However, SureSource forms incorporate substantially more data points than typical CRFs (on average 35% of the data is CRF data while 65% relates to source fields). Additionally, up to 90% of standard CRF edit checks are built into the eSource forms and fire automatically at the time of a subject visit to ensure optimal data and research quality.

Q: How does SureSource impact Monitors?

SureSource can help optimize monitoring activities. Since source data is available in near real-time, through the SureSource Insight Portal, Monitors can centrally review documents, reducing the need to travel, and work with sites earlier to ensure proper protocol execution. Since SureSource is capturing the source data and the eCRF data at the same time, during the patient visit, data errors are reduced and the need to verify source data is drastically reduced. SureSoure enables monitors to shift their focus away from minimally effective and time-intensive monitoring SDV activities to higher value activities, such as patient recruitment and building relationship with sites.

Q: How does SureSource impact Data Managers?

SureSource provides significantly more data than traditional EDC systems to provide data managers with a more complete context of clinical data. Data queries are significantly reduced as much as 90% compared to standard CRF forms because SureSource edit checks fire at the time of the subject visit — when data can be corrected more easily. SureSource can automate manual data mapping and transposition processes via integrations that connect the SureSource clinical database to various ad-hoc reporting tools (e.g. J-Review, Spotfire, Comprehend). Using the SureSource Insight portal, Data Managers are given additional tools to facilitate their clinical data review. Data Managers can review study data in a domain by domain workflow, with built-in filtering options to streamline their review as well as providing query management features, all within one place. At any time during a review, study team members have access to view the source form from which a potential questionable data field originated, to provide the necessary context that would traditionally only be attained from a site visit.

Q: How does SureSource interact with Electronic Medical Records?

Like any EDC system, SureSource does not directly integrate with or replace a site electronic medical record (EMR). However, using SureSource, sites can download source documents as a PDF document for inclusion in a site EMR. Also like EDC, data originally entered into an EMR (e.g. MedHx or ConMeds) must be transcribed into SureSource. Document exports out of an EMR can be uploaded into SureSource for remote review.

Q: Can the SureSource platform integrate with other systems?

SureSource has the ability to integrate with a wide range of clinical trial systems, such as IWRS and electronic informed consent systems. During the initial build phase, the scope of work and necessary APIs are defined between SureSource and the additional vendors to align all necessary workflows. Testing of both SureSource and vendor system integrations happen during the normal study build UAT, and are fully verified prior to live study deployment.

Q: How is data exported from the SureSource platform?

When the study build begins, mapping specifications are configured between the Sponsor and Clinical Ink Data management team. Once defined and tested, export frequencies are established to provide data exports in a timeframe and format requested by the study team. Web services are available to pull data directly from the SureSource platform, and are configured at the time of study build.

Q: What is JReview?

JReview is the fastest, easiest way to review, graph, report and analyze clinical data. A web-enabled software application, JReview has been developed over the past 20 years to provide a more comprehensive set of functionality targeted specifically for use by clinicians, data managers, QA and medical writers doing clinical research at pharmaceutical, biotech and medical device companies.

Q: How does integration with JReview help Clinical Ink further streamline the clinical trial process?

The integration of SureSource and JReview provides Clinical Ink customers with direct, immediate access to all SureSource data — including CRF and non-CRF information — for real-time analysis and reporting via JReview. This streamlined approach reduces the time and cost required to analyze data while providing a more complete informational context for risk-based monitoring.

Q: How can SureSource and JReview improve risk-based monitoring?

Clinical Ink’s SureSource platform captures both CRF and non-CRF data (i.e. who entered/changed data and when) which provides 200 percent more data than traditional paper-based data capture. All SureSource data is accessible by JReview for risk-based analysis using features that include:

Q: What is patient engagement?

Patient engagement in clinical research refers to a patient’s understanding, involvement, communication and satisfaction as an active participant in a clinical study. The purpose of patient engagement in clinical research is to improve retention, compliance and satisfaction by building mutually beneficial collaborations between patients and investigators via two-way communication. This communication may include patient education, reminders, data sharing, scheduling assistance, etc.

Q: Why is patient engagement important in clinical research?

A key challenge to clinical trials today is keeping patients motivated, compliant and engaged with the clinical trial protocol. However, lengthy trials, complex trial designs, lack of motivation, unexpected risks, adverse events, poor communication of trial outcomes and excessive travel to investigator sites can act as roadblocks to retaining patients. Participants who fail to comply with clinical trial protocol, drop out of a clinical study or remain disengaged not only jeopardize the quality and integrity of data, but also contribute to rising costs and development timelines. As such, sponsors face overwhelming demands to increase the pool of volunteers for enrollment in clinical trials while maintaining effective programs to improve patient engagement. Engaging patients early and often is the way to better study results, shorter timelines and reduced costs.

Q: Where does the pharmaceutical industry stand in terms of mobile patient engagement technology adoption?

The pharmaceutical industry has embraced the term, ’beyond the pill,’ which is a strategy designed to create value via a range of valueadded services — primarily digital. Patient engagement technology is part of the ‘beyond-the-pill’ value chain that can improve patient outcomes and provide competitive advantages. As a new market and new technology, most companies have limited buying experience and education about these solutions and the potential impact on clinical trial outcomes.

Q: How can mobile technology improve patient engagement?

The ubiquity of mobile technologies, specifically smartphones, has increased popularity of patient-centric mobile applications which allow study teams to directly engage with and capture data from clinical trial participants. The integration of mobile technology in new clinical trial designs and business strategy development holds promise for aligning site and patient needs with faster study execution and reduced costs.

Q: What is the regulatory (FDA/EMA) stance on patient engagement?

Both the FDA and EMA support increased engagement with patients and consumers via mobile technologies for improved development and safety. The FDA encourages more patient-focused drug development and has recently enacted various initiatives that proactively solicit patient feedback as part of the drug development process. Since the 1990s, the FDA has worked with patient advocates to evaluate drugs or medical devices that were close to approval. In 2012, the PatientFocused Drug Development (PFDD) program was signed into law to more systematically obtain the patient’s perspective on a disease much earlier in the development process to understand its impact on daily lives, the types of treatment benefit that matter most to patients, and the adequacy of available therapies for the disease.

A June 2012 presentation by FDA’s Theresa Mullin, PhD., entitled “Patient-Focused Drug Development,” highlights the PFDD initiative to collect patient-reported outcomes (PROs) during drug development to better assess effectiveness and guide drug development. Similarly, the FDA’s Patient Representative Program seeks to incorporate the unique perspectives of patient advocates on serious or life-threatening conditions into the drug development process.

Once cleaned and monitored, data captured in a data management system – whether via EDC or imported labs, IVRS/IWRS, ePRO, etc. – is ultimately exported to datasets for analysis and/or submission. Statisticians and programmers devote an extensive amount of time and effort to complete this process manually. SureSource DTE automates this process to minimize clinical trial costs and timelines.

Q: How does SureSource DTE work?

SureSource DTE features a drag and drop tool that allows users to define export data domains. Users can map and transform the data collection data model to the export domains and map to industry standards, including SDTM. Mapping can be defined once the data collection model has been defined, and before final data is collected.

Once data is locked, end users select frequency and timing preferences for running final exports (i.e. immediate, scheduled or on-demand). All data exports — including custom templates — are validated and repeatable for data listing, SAS extracts, subject profiles, and CDISC SDTM exports used for regulatory submission.

Q: What are key customer benefits of SureSource DTE?

Regulatory Compliance: The FDA will soon mandate that all clinical data submissions conform to SDTM

Reduced Clinical Development Timelines: Current processes for clinical data submissions require 3-6 weeks after database lock – when all EDC data is collected and cleaned at the END of the study — before data is transformed into SDTM. SureSource DTE will deliver SDTM data sets within 48 hours of database lock.

Q: What is the EU GENERAL DATA PROTECTION REGULATION (EU GDPR)?

The EU GDPR is set to replace the Data Protection Directive (95/46/EC) on May 25, 2018. The new law encompasses all organizations that handle data of persons (data subjects) in the European Union.

Q: What is Clinical Ink doing to comply with GDPR?

Data Protection is the highest priority at Clinical Ink. As a part of our ongoing efforts to ensure compliance for our customers and their data, Clinical Ink undertook an assessment of the GDPR. Prior to this analysis, Clinical Ink has, over the past few years, registered and certified against Safe Harbor and the Privacy Shield, which demonstrated our compliance with the EU Data Protection Directive. We have established that Clinical Ink fully meets the expectations of the GDPR and ensuring the protection and safeguarding of data collected for the purposes of conducting the clinical trial.

Q: Where does Clinical Ink store data?

Clinical Ink stores data through its infrastructure and cloud hosting provider, AWS, in the US-East region and EU-West region.

Q: How long is the SureSource data stored?

The data collected through Clinical Ink’s SureSource applications is stored on encrypted drives provisioned in the corresponding region for online access and archived to AWS Glacier for long- term archival. The length is determined by each customer-specific project contract. As a data processor, Clinical Ink will follow the requirements of the data controller (study sponsor – in this case) when it comes to data storage and retention.

Q: What is privacy shield and why does Clinical Ink maintain a privacy shield certification?

The Privacy Shield Program is a framework agreed to by the U.S. Department of Commerce and the European Commission to ensure adequate privacy protections for European Union (EU) persons when their personal data is moved outside Europe.
Privacy Shield allows for U.S companies to transfer data from Europe to the United States. As a U.S.- based company, Clinical Ink aims to provide the highest level of data privacy and protection for all customers and users. Clinical Ink is committed to meet this standard by annually self-certifying against the Privacy Shield regulation.

Q: Are there any GDPR-Related certifications?

The GDPR encourages the development of a certification procedure, particularly on the Union- level, and Clinical Ink will closely monitor & review newly developed GDPR certification procedures to decide how to further demonstrate its commitment to the standard set forth in the GDPR.